Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
This study is gathering information on a small, implanted heart monitor called the BIOTRONIK Implantable Cardiac Monitor (ICM). It's designed for people who are getting one of these devices to help doctors understand heart conditions like fast or slow heartbeats, irregular rhythms (atrial fibrillation), or unexplained fainting (syncope). The main goal is to see how well the monitor works and how safe it is over the long term, in day-to-day life. It also allows for smaller, related studies to be added later without much extra effort for patients or clinics. This information helps improve patient care and device design in the future.
At a glance
What is this study about?
Imagine you're having symptoms like your heart racing, beating too slowly, or you've fainted without a clear reason. Sometimes, doctors need to keep a close eye on your heart's electrical activity over a long period to figure out what's going on. This is where a small device called an Implantable Cardiac Monitor (ICM) comes in handy – it's placed just under your skin and records your heart's rhythm continuously.
This study is a bit like keeping a diary about how these ICMs work for people like you. It's called a 'registry,' which means doctors are simply observing and collecting information from patients who are already going to have one of these monitors fitted as part of their usual care. They want to learn more about how well the device performs over time and ensure it remains safe in real-world situations, outside of typical research settings.
The information gathered will help doctors and device manufacturers understand more about various heart conditions and how effectively the ICM helps monitor them. This knowledge can lead to better treatments and improved care for people with heart rhythm problems, irregular heartbeats, unexplained fainting, or even those who have had a stroke without a known cause.
Key takeaways
- This study observes real-life use of a small heart monitor (ICM).
- It aims to understand how well the monitor works and its safety over time.
- Patients must be 18 or older and planning to receive an ICM.
- Participation involves using a home monitor to send heart data.
- No new treatments or risks are part of this observation study.
- Your medical care won't change if you participate.
Who may be eligible?
To join this study, you must be planning to have a BIOTRONIK Implantable Cardiac Monitor (ICM) fitted by your doctor. You need to be able to understand what the study is about and agree in writing to take part. It's also important that you are willing and able to use a small device called a CardioMessenger, which helps send information from your monitor to your doctor from your home, and that you are happy with how this system works.
There are a few reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you are under 18 years old, you wouldn't be eligible. Also, if you are already taking part in another type of medical research that involves trying out new treatments or devices, you would not be able to participate in this study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Is your doctor planning for you to have a BIOTRONIK heart monitor (ICM) fitted?
- Can you understand and sign a consent form for the study?
- Are you willing to use a home monitoring device (CardioMessenger) to send data?
- Are you NOT pregnant or breastfeeding?
- Are you NOT already in another study testing a new treatment or device?
What does participation involve?
If you decide to take part, it generally involves your doctor fitting the small heart monitor (ICM) as they normally would. You will then use a small device called a CardioMessenger at home, which automatically sends information from your heart monitor to your doctor. This 'Home Monitoring' is a key part of the study, and you'll receive instructions on how to use it. There are no extra hospital visits specifically for this study beyond your usual medical appointments related to your heart condition and the monitor. The study will observe your routine care over the long term, so there isn't a specific end date for your participation; it aligns with how long you have your monitor and receive care for your heart condition.
Potential risks and benefits
Locations (31)
- Integral HealthVerified postcodeAdelaide, Australia· Recruiting
- Royal Adelaide HospitalVerified postcodeAdelaide, Australia· Completed
- Nemocnice Ceske Budejovice, a.s.Verified postcodeČeské Budějovice, Czechia· Recruiting
- Hôpital Saint-AndréVerified postcodeBordeaux, France· Completed
- Le Centre Hospitalier Universitaire de Brest (CHRU Brest)Verified postcodeBrest, France· Recruiting
- Le Centre Hospitalier Universitaire de Caen (CHRU Caen)Verified postcodeCaen, France· Recruiting
- Le Centre Hospitalier Universitaire de Tours (CHRU Tours)Verified postcodeChambray-lès-Tours, France· Active not recruiting
- Hôpital Gabriel MontpiedVerified postcodeClermont-Ferrand, France· Recruiting
- Hôpital Haut Lévêque (CHU)Verified postcodePessac, France· Recruiting
- Hôpitaux Universitaires de StrasbourgVerified postcodeStrasbourg, France· Recruiting
- St. Marienkrankhaus Klinikum Westmünsterland GmbHVerified postcodeAhaus, Germany· Recruiting
- Kerckhoff-Klinik GmbHVerified postcodeBad Nauheim, Germany· Recruiting
Common questions
What is an Implantable Cardiac Monitor (ICM)?
It's a small heart recorder placed under your skin to wirelessly track your heart's rhythm over time.
Will this study change my medical treatment?
No, this study only observes your usual care. Your doctor's treatment plan will not change because you are in the study.
What is a CardioMessenger?
It's a small device you keep at home that automatically sends your heart monitor's readings to your doctor.
Is the study suitable for children?
No, you must be 18 years or older to take part in this study.
Can I leave the study if I change my mind?
Yes, you can choose to stop participating at any time without it affecting your medical care.
How to find out more
Sabrina Hoche, Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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